Zinvel Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Zoledronic acid

Indications/Uses

Hypercalcemia of malignancy. Multiple myeloma & bone metastases from solid tumors in conjunction w/ standard antineoplastic therapy.

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Dosage/Direction for Use

Hypercalcemia of malignancy Max recommended dose: 4 mg (diluted in 100 mL NaCl 0.9% or dextrose 5%) as single dose IV infusion over not <15 min. Retreatment w/ 4 mg may be considered if necessary after minimum of 7 days has elapsed. Multiple myeloma & metastatic bone lesions of solid tumors Patients w/ CrCl >60 mL/min 4 mg (diluted in 100 mL NaCl 0.9% or dextrose 5%) infused over not <15 min every 3-4 wk, 50-60 mL/min 3.5 mg, 40-49 mL/min 3.3 mg, 30-39 mL/min 3 mg.

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Overdosage

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Contraindications

Hypersensitivity.

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Special Precautions

Not recommended in patients w/ bone metastases w/ severe renal impairment. Discontinue use if severe symptoms of musculoskeletal pain develop. Osteonecrosis of the jaw. Bronchoconstriction in aspirin-sensitive patients. Adequately rehydrate patients w/ hypercalcemia of malignancy prior to administration. Avoid overhydration in patient w/ cardiac failure. Monitor serum levels of Ca, phosphate, Mg & creatinine following initiation of therapy. Concomitant use w/ loop diuretics & other nephrotoxic drugs. Renal & hepatic impairment. Not to be used during pregnancy. Not to be administered to a nursing woman. Not for use in childn. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Bone & muscle pain, nausea, constipation, fatigue, confusion, hallucination, anemia, vomiting, weakness, anorexia, fever, dyspnea, eye irritation, hypocalcemia, headache, diarrhea & hypophosphatemia.

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Drug Interactions

May have additive effect in lowering serum Ca level w/ aminoglycosides (prolonged use). Increased risk of hypocalcemia w/ loop diuretics. Nephrotoxic drugs. May increase risk of renal dysfunction in multiple myeloma patients w/ thalidomide.

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Storage

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Description

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Action

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MIMS Class

Agents Affecting Bone Metabolism

ATC Classification

M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.

Regulatory Classification

POM

Presentation/Packing

Form

Zinvel inj 4 mg/5 mL

Packing/Price

1's

Zinvel

zoledronic acid

Manufacturer:

Gland Pharma

Distributor:

Maxxcare

Marketer:

Mega Lifesciences